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Software Validation Engineer

Portland, ME

Contact Details

  • Company: Vantage Point Recruiting
  • Contact Name: Uli Stewart
  • Contact Email:
  • Career Website: https://vantagepointrecruiting.com/your-career/
  • Contact Phone: 2076502216

Job Description

The Software Validation Engineer will work cross-functionally to assist departments with selection, development, integration and validation of software.

Responsibilities:

  • ​​Develop software user requirement specifications and test plans to establish fit and function of software (custom and off-the-shelf) used to support the Quality Management System (QMS) within an highly regulated biotech manufacturing facility.​
  • Execute software validation protocols.
  • Collaborate with quality assurance department to ensure that all software validation documentation adheres to company policies and regulatory guidelines.
  • Maintain site software systems master inventory.

Desired Skills:

  • Experience working in a highly regulated industry (manufacturing and quality system standards, a plus).
  • Software verification and validation experience.
  • Strong communication and technical writing skills.
  • Attention to detail.

Education/Background: Engineering, Computer Science or Information Technology degree